[Federal Register Volume 68, Number 45 (Friday, March 7, 2003)]
[Notices]
[Pages 11120-11121]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-5353]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0528]


Risk Management; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop, request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
workshop to discuss risk management activities for drug and biological 
products (excluding blood products other than plasma derivatives). The 
purpose of the workshop is to present FDA's current thoughts on risk 
management activities and to solicit views from the public. To 
facilitate public input and discussion, FDA is issuing for review and 
comment three concept papers that focus on risk assessment, risk 
management, and pharmacovigilance. The input received at the workshop 
and from comments on the concept papers will be considered in drafting 
guidance for industry.

DATES: The public workshop will be held on April 9, 10, and 11, 2003, 
from 8 a.m. to 4:30 p.m. Submit written or electronic requests to 
preregister to speak by March 21, 2003. Written or electronic comments 
on the concept papers will be accepted until April 30, 2003. However, 
to have your comments considered at the workshop, submit them by March 
21, 2003.

ADDRESSES: The public workshop will be held at the National 
Transportation Safety Board Boardroom and Conference Center, 429 
L'Enfant Plaza, SW., Washington, DC 20594; 202-314-6421. The center may 
be reached by Metro, using the L'Enfant Plaza Station on the green, 
yellow, blue, and orange lines) http://www.ntsb.gov/events/newlocation.htm. Seating is limited and will be available on a first-
come first-served basis each day of the workshop.
    Submit written or electronic requests to speak and comments to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852; e-mail 
[email protected]; or on the Internet at http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. Transcripts 
of the workshop will be available for review at the Dockets Management 
Branch (see address above) and on the Internet at http://www.fda.gov/ohrms/dockets.

FOR FURTHER INFORMATION CONTACT:
For media and press inquiries: Jason Brodsky, Office of Public Affairs 
(HFI-020), Food and Drug Administration, 5600 Fishers Lane, Rockville, 
MD 20857 301-827-6242, [email protected].
For all other inquiries: Lee Lemley, Center for Drug Evaluation and 
Research (HFD-006), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-594-6218, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    On June 12, 2002, the President signed the Public Health Security 
and Bioterrorism Preparedness and Response Act of 2002 (Public Law 107-
188), which includes the Prescription Drug User Fee Amendments of 2002 
(Public Law 102-571) (PDUFA 3). In exchange for receiving user fees 
under PDUFA 3, FDA agreed to certain performance goals. As one of its 
PDUFA 3 goals, FDA agreed to produce guidance for industry on risk 
management activities. Specifically, FDA intends to produce three 
guidance documents by September 30, 2004, addressing: Good risk 
assessment, risk management, and pharmacovigilance practices for drug 
and biological products (excluding blood products other than plasma 
derivatives). As an initial step, three joint Center for Drug 
Evaluation and Research (CDER)/Center for Biologics Evaluation and 
Research (CBER) working groups have developed concept papers outlining 
FDA's preliminary thoughts for providing guidance for industry. The 
concept papers are available at FDA's Dockets Management Branch and on 
the Internet (http://www.fda.gov/cder/meeting/riskmanagement.htm). FDA 
welcomes written and electronic comments on the concept papers (see 
section IV of this document).

II. Scope of Workshop and Concept Papers

    At this public workshop, FDA is interested in receiving comments 
from stakeholder groups likely to be affected by its risk management 
activities. Stakeholder groups of interest include, but are not limited 
to: Consumer groups, physicians, nurses, pharmacists, drug and 
biological product manufacturers, and third party payers for health 
care services and medical products.
    Each day of the 3-day workshop will focus on one aspect of risk 
management activities, including: (1) Premarketing risk assessment on 
April 9, 2003, (2) risk management programs and planning on April 10, 
2003, and (3) pharmacovigilance and pharmacoepidemiologic assessment on 
April 11, 2003.

A. Premarketing Risk Assessment (April 9, 2003)

    Risk assessment is the process of identifying, estimating, and 
evaluating the nature and severity of risks associated with a product 
throughout its lifecycle. On April 9, 2003, the public workshop 
discussion will focus on good risk assessment practices during product 
development. Specifically, the discussion will focus on issues raised 
by the concept paper ``Premarketing Risk Assessment'' (http://www.fda.gov/cder/meeting/riskmanagement.htm). This concept paper 
presents FDA's preliminary thoughts on:
    1. Important risk assessment concepts,
    2. Generation and acquisition of safety data during clinical 
trials, and
    3. Analysis and presentation of safety data in an application for 
approval

B. Risk Management Programs and Planning (April 10, 2003)

    Risk management is the overall and continuing process of minimizing 
risks throughout a product's lifecycle to optimize its benefit/risk 
balance. On April 10, 2003, the public workshop discussion will focus 
on the

[[Page 11121]]

development, implementation, and evaluation of strategic safety 
programs designed to decrease a product's risks. Specifically, the 
discussion will focus on issues raised by the concept paper ``Risk 
Management Programs'' (http://www.fda.gov/cder/meeting/riskmanagement.htm). This concept paper presents FDA's preliminary 
thoughts on:
    1. Considerations on what comprises and prompts a risk management 
program,
    2. The selection and development of risk management tools,
    3. The evaluation of risk management programs, and
    4. The recommended elements of a risk management program submission 
to FDA.
    Comments on evaluation methods and overall concepts are requested, 
in particular, from academicians and others with experience in outcomes 
research in health care quality or pharmacoepidemiology.

C. Risk Assessment of Observational Data: Good Pharmacovigilance 
Practices and Pharmacoepidemiologic Assessment (April 11, 2003)

    Pharmacovigilance is generally regarded as all postapproval 
scientific and data gathering activities relating to the detection, 
assessment, understanding, and prevention of adverse events or any 
other product-related problems. On April 11, 2003, the public workshop 
discussion will focus on the assessment of a product's risk profile as 
identified from observational data sources (including case reports, 
case series, and pharmacoepidemiologic studies). Specifically, the 
discussion will focus on issues raised by the concept paper ``Risk 
Assessment of Observational Data: Good Pharmacovigilance Practices and 
Pharmacoepidemiologic Assessment'' (http://www.fda.gov/cder/meeting/riskmanagement.htm). This concept paper presents FDA's preliminary 
thoughts on:
    1. Important pharmacovigilance concepts,
    2. Safety signal identification,
    3. Pharmacoepidemiologic assessment and interpretation of safety 
signals, and
    4. The development of pharmacovigilance plans.
    In particular, in this segment of the public workshop, FDA is 
interested in receiving public input on the following questions:
    1. How can the quality of spontaneously reported case reports be 
improved?
    2. What are possible advantages or disadvantages of applying 
datamining techniques (e.g., empirical Bayesian techniques, 
proportional reporting ratios) to spontaneous reports databases for the 
purpose of identifying safety signals?
    3. What are possible advantages or disadvantages of performing 
causality assessments at the individual case level?
    4. Under what circumstances would a registry be useful as a 
surveillance tool and when would it cease to be useful?
    5. Under what circumstances would active surveillance strategies 
prove useful to identify as yet unreported adverse events?
    6. Under what circumstances would additional pharmacoepidemiologic 
studies be useful?

III. Registration and Requests for Oral Presentations

    To speak at the workshop you must preregister by March 21, 2003. 
Requests must be submitted electronically or in writing. In your 
request to speak, you should state the: (1) Day of the workshop when 
you would like to speak; (2) specific issue related to that day's topic 
that you intend to address; (3) names and addresses of all individuals 
that plan to participate; and (4) approximate time requested to make 
your presentation. Electronic requests to speak at the workshop may be 
submitted at http://www.accessdata.fda.gov/scripts/oc/dockets/meetings/meetingdocket.cfm. Requests to speak will be accepted on a first-come, 
first-served basis. Individuals who register to speak will be notified 
of the scheduled time for their presentation before the workshop and 
will have reserved seating. Depending on the number of speakers, FDA 
may need to limit the time allotted for each presentation. Speakers 
must submit two copies of each presentation by the date they have 
registered to speak. If you need special accommodations due to a 
disability, please inform the registration contact person when you 
register. Presentations should be limited to the topics addressed in 
the concept papers. Preregistration is not necessary if you are not 
speaking and plan to come only as an attendee to the workshop. However, 
seating is limited and will be available on each of the workshop days 
on a first-come first-served basis.

IV. Request for Comments

    Regardless of attendance at the workshop, interested persons may 
submit written or electronic comments on the concept papers to the 
Dockets Management Branch (see ADDRESSES). You should annotate and 
organize your comments to identify the specific concept paper and issue 
to which they refer. Where possible, comments should reference line 
numbers in the concept papers. Two copies of any mailed comments are to 
be submitted, except that individuals may submit one copy. Comments are 
to be identified with the docket number found in brackets in the 
heading of this document. The concept papers and received comments may 
be seen at the Dockets Management Branch between 9 a.m. and 4 p.m., 
Monday through Friday. Transcripts of the hearing also will be 
available for review at the Dockets Management Branch.

V. Electronic Access

    Electronic versions of the concept papers are available via 
Internet using the World Wide Web at http://www.fda.gov/cder/meeting/riskmanagement.htm.

    Dated: March 3, 2003.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 03-5353 Filed 3-6-03; 8:45 am]
BILLING CODE 4160-01-S